The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have announced they will supply an additional 100 million doses of their COVID-19 vaccine to the 27 European Union (EU) member states in 2021.
This announcement is a result of the...
Johnson & Johnson (J&J) has provided updates on the manufacturing of its COVID-19 vaccine as well as on its rollout in the US and Europe.
On the manufacturing front, J&J reported that it is working closely with the US...
Vertex Pharmaceuticals and CRISPR Therapeutics, a Swiss-US-based company developing therapeutics based on CRISPR-Cas9 gene-editing technology, have formed a $1.1-billion pact to develop, manufacture, and commercialize CRISPR Therapeutics’ CTX001,...
Bristol-Myers Squibb (BMS) has announced plans for a new cell-therapy manufacturing site in Leiden, the Netherlands.
Planning for site design and development is underway with construction slated to begin later this year (2021). Leiden will be BMS’...
Amgen has completed its previously announced acquisition of Five Prime Therapeutics, a South San Francisco, California-based company developing immuno-oncology and targeted cancer therapies, for approximately $1.9 billion. Amgen had announced the...
Johnson & Johnson (J&J) has provided an update regarding a pause of use of its COVID-19 vaccine.
Earlier this week (as reported on April 15, 2021), the US Food and Drug Administration (FDA) and the US Centers for Disease Control and...
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Novartis, Moderna, Pfizer, Lilly, AstraZeneca, Merck & Co., Regeneron, Thermo Fisher, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
Novartis in Pact...
Patrizia Cavazzoni, M.D., has been appointed as Director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). She has served as Acting Director for the past year.
She succeeds Janet Woodcock, M.D., now Acting...
Sanofi has completed two acquisitions: Kymab, a Cambridge, UK-based biopharmaceutical company, in a $1.45-billion deal ($1.1 billion upfront and up to $350 million in milestones) and Tidal Therapeutics, a Cambridge, Massachusetts-based company...
Sanofi plans to invest EUR 400 million ($477 million) over five years to create a vaccine-production site in Singapore.
In partnership with the Singapore Economic Development Board, the new site will mainly supply the Asian region and complement...
The European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) report that a possible link between AstraZeneca’s COVID-19 vaccine and a combination of blood clots and low blood platelets is very rare and...
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, has provided updates on the contract manufacturing of two COVID-19 vaccines respectively from Johnson & Johnson (J&J) and...
A roundup of news from Egypt (Bausch Health), Japan (Daiichi Sankyo, Sanofi), UK (AstraZeneca), and the US (Merck & Co., Sandoz, Zydus, Alembic, and Apotex).
Egypt
Bausch Health To Sell Amoun Pharmaceuticals for $740 M Bausch Health Companies...
Merck & Co. has completed its $1.85-billion acquisition of Pandion Therapeutics, a Watertown, Massachusetts-based company developing bispecific antibody therapeutics for autoimmune diseases. It also has separately agreed to acquire Alydia...
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Moderna, Pfizer, Lilly, Takeda, CSL, Novavax, Sinovac, Emergent BioSolutions, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
FDA Revises Doses Per Vial...
